1. Intelligently Linking Information Systems Copyright 2008, Rensis Corporation. All rights reserved. Rensis Corporation HIPAA Transactions The Next Generations David. A. Feinberg, C.D.P. President, Rensis Corporation 206-617-1717DAFeinberg@computer.org 1 20 August 2008

2. Rensis Corporation © 2008, Rensis Corporation Today’s Session Objective: Provide information that allows impacted organizations to track and participate in future HIPAA transactions activities; thereby managing their futures Topics: Materials Used in HIPAA Transactions Processes for Creating Materials Status, Predictions, and Key Issues Obtaining Further Information 2

3. Rensis Corporation © 2008, Rensis Corporation Caveats For clarity and simplicity, today’s discussion primarily illustrates the ANSI SDO processes of Accredited Standards Committee X12. Similar but differing processes also exist at other HIPAA SSO’s. The predictions contained in today’s presentation are solely those of the author and do not represent the views, official or unofficial, of anybody else. 3

4. Rensis Corporation © 2008, Rensis Corporation Materials 4 837 Pro. 837 Inst. 837 Dental CFR

5. Rensis Corporation © 2008, Rensis Corporation HIPAA Transactions Specifications Mandatory Federal Regulations [“Rules”] which “adopt” and promulgate Voluntarily published X12 (and equivalent) Type 3 Technical Reports (TR3’s) a.k.a. “HIPAA Standards” which define precise uses of Voluntarily published X12 Standards 5 Note: X12 Type 3 Technical Reports are presently known as Implementation Guides

6. Rensis Corporation © 2008, Rensis Corporation HIPAA X12 Standards X12 TR3’s Federal Reg’s 6 THE H I P A S O L A R S Y S T E M

7. Rensis Corporation © 2008, Rensis Corporation X12 Standards Publication Cycle Publisher Governing Materials Authoring Entities Supporting Entities 3 times a year Data Interchange Standards Association Standing Doc. 2 (SD2) X12N Workgroups X12N / TG8 (Architecture) X12J (Tech. Assessment) Procedures Review Board (PRB) 7

8. Rensis Corporation © 2008, Rensis Corporation X12 Type 3 Technical Reports Publication Cycle Publisher Governing Materials Authoring Entities Supporting Entities attempted every 2 years, but was too rapid Washington Publishing Co. IG Handbooks X12N Workgroups X12N / TG4 (IG Coord.) X12J (Tech. Assessment) Note: X12 Type 3 Technical Reports are presently known as Implementation Guides 8

9. Rensis Corporation © 2008, Rensis Corporation Federal Regulations Publication Cycle Publisher Governing Materials Authoring Entity Supporting Entities as recommended Government Printing Office HIPAA Legislation Administrative Procedures Act Paperwork Reduction Act CMS’ Office of eHealth Stds. DSMO Steering Committee NCVHS 9

10. Rensis Corporation © 2008, Rensis Corporation Processes 10 SD2 IG Handbooks 42 USC 1320d 45 CFR 162.910 5 USC 551-553, 808 EO 12866 DSMO MOU 63 FR 88, pp 25274-25294 45 CFR 160.500-572

11. Rensis Corporation © 2008, Rensis Corporation Transactions Processes Updating and creating new X12 standards; including internal code lists Creating and modifying Type 3 Technical Reports (TR3’s); including internal code lists subsets Adopting TR3’s for HIPAA 11

12. Rensis Corporation © 2008, Rensis Corporation Updating Standards X12 has two formal processes documented in Standing Document 2 (SD2) °Data Maintenance (DM) For message structure, format, data element definitions, and internal code lists values Can take many months or years °Code Maintenance Request (CMR) For internal code lists values only Expedited process to speed-up changes Can still take 4 – 8 months 12 SD2

13. Rensis Corporation © 2008, Rensis Corporation Creating and Modifying TR3’s X12N process summary °Work groups within parent task groups, in conjunction with Washington Publishing Company, establish schedule [including change request cutoff dates for various sources] and then create new TR3’s °Following internal approvals for technical accuracy and proper process from supporting task groups, work groups initiate X12N public comment period for new TR3’s 13 continued on next slide... ?

14. Rensis Corporation © 2008, Rensis Corporation Creating and Modifying TR3’s X12N process summary °TR3’s public comment period occurs – targeted for 60 days, but can be 30 – 90 °Work groups resolve any issues raised during public comment period and make any needed adjustments to TR3’s °Work groups hold public Informational Forums during X12 Trimester Meetings to confirm resolved issues and TR3’s adjustments 14 continued on next slide... ?

15. Rensis Corporation © 2008, Rensis Corporation Creating and Modifying TR3’s X12N process summary °Work groups vote to move TR3’s to parent task group for publication approval – only TG2 (Healthcare), at present °Task groups vote to move TR3’s to subcommittee X12N (Insurance) for publication approval °X12N approves TR3’s for publication 15 continued on next slide...

16. Rensis Corporation © 2008, Rensis Corporation Creating and Modifying TR3’s X12N process summary °Any other affected X12 subcommittees [e.g., X12F (Finance)] approve TR3’s for publication [ new for TR3’s ] °X12J – Technical Assessment subcommittee approves TR3’s for publication [ new for TR3’s ] °Procedures Review Board is notified that TR3’s are ready for publication [ new for TR3’s ] °Washington Publishing Company publishes 16 IG Handbook

17. Rensis Corporation © 2008, Rensis Corporation Adopting TR3’s for HIPAA 17 Notice and Comment (NPRM) rule making – process used to date Legislated – was in the works for °X12 version 005010 °NCPDP version as of April, 2007 Streamlined rule making – also was in the works for versions beyond Legislated HIPAA transaction standards was HR4157 in 109 th Congress; needs to be re-introduced

18. Rensis Corporation © 2008, Rensis Corporation NPRM Adoption Process Two cycle process – first iteration X12N proposes new version of published Type 3 Technical Reports (TR3’s) Designated Standards Maintenance Organizations (DSMO) Steering Committee approves new version National Committee on Vital and Health Statistics (NCVHS) recommends new version 18 continued on next slide...

19. Rensis Corporation © 2008, Rensis Corporation Centers for Medicare and Medicaid Services (CMS) prepares Notice of Proposed Rule Making (NPRM) announcing new version Department of Health and Human Services (DHHS) clears NPRM Other affected federal agencies (e.g., Office of Management and Budget) approve NPRM 19 continued on next slide... NPRM Adoption Process

20. Rensis Corporation © 2008, Rensis Corporation NPRM is published in Federal Register NPRM public comment period occurs – normally 60 days – covers “policy” and TR3’s…again CMS, with any needed support from DSMO Steering Committee, X12N, et. al., analyzes comments received about NPRM 20 continued on next slide... NPRM Adoption Process

21. Rensis Corporation © 2008, Rensis Corporation Two cycle process – second iteration Based on received comments, if necessary, X12N incorporates changes into next published new version of TR3’s DSMO Steering Committee approves new version NCVHS recommends new version CMS prepares Final Rule promulgating new version 21 ? continued on next slide... NPRM Adoption Process

22. Rensis Corporation © 2008, Rensis Corporation DHHS clears Final Rule Other affected federal agencies (e.g., OMB) approve Final Rule 22 NPRM Adoption Process continued on next slide...

23. Rensis Corporation © 2008, Rensis Corporation Final Rule or Notice is published in Federal Register °Specifies explicit Effective Date [Effective Date also known as Adoption Date] °Specifies explicit Compliance Date(s) For an existing HIPAA standard, any Effective Date for a modified standard must be at least 12 months following any previous Effective Date 23 continued on next slide... NPRM Adoption Process

24. Rensis Corporation © 2008, Rensis Corporation Effective Date occurs no earlier than the end of mandatory Congressional Review period which is normally 60 days Compliance Date(s) °New Standards – 24 months after Effective Date; small health plans get 36 months °Modified Standards – established within the Final Rule, but must be at least 180 days after Effective Date 24 NPRM Adoption Process

25. Rensis Corporation © 2008, Rensis Corporation Status, Predictions, and Key Issues 25 as of 20 July 2008

26. Rensis Corporation © 2008, Rensis Corporation David A. Feinberg, C.D.P. Consultant and Teacher -- Healthcare Interfaces and EDI Author, “Understanding HIPAA Communications” Member, Accredited Standards Committee X12 and its Insurance Subcommittee (X12N) Member and past co-chair, X12N HIPAA Implementation and Coordination Work Group Member, Health Level Seven (HL7) Member, HL7 Attachments Special Interest Group (ASIG) and X12N Patient Information Work Group (TG2/WG9) Member, concluded HL7 Master Person Index Mediation Special Interest Group (MPISIG) Commercial and Technology Arbitrator, American Arbitration Association 26

27. Rensis Corporation © 2008, Rensis Corporation Transactions Futures Claims Attachments New Versions of Current Transactions Potential New Transactions 27

28. Rensis Corporation © 2008, Rensis Corporation Claims Attachments Defined by HL7 Attachments Special Interest Group (ASIG) in “Specifications” Presently proposed to incorporate XML within EDI; i.e., °X12’s 275 transaction … contains HL7’s Clinical Document Architecture (CDA R2) … made up of –Structured data elements, –Narrative, unstructured, text, and/or –Scanned, non-diagnostic, images [many formats] 28 continued on next slide...

29. Rensis Corporation © 2008, Rensis Corporation Claims Attachments Proposed First Round °Ambulance °Emergency Department °Rehabilitative Services °Laboratory Results °Medications °Clinical Notes 29

30. Rensis Corporation © 2008, Rensis Corporation Claims Attachments Status °First proof of concept pilot project completed Small subset of types, variants, options, choices Not 100% successful Successful pilot pair in production –Montefiore Medical Center and National Government Services (nee Empire Medicare Services) + Mayo Clinic and Wisconsin Physicians Service °NPRM incorporating X12 and HL7 materials published on 9/23/2005; public comment period closed on 1/23/2006 30 continued on next slide...

31. Rensis Corporation © 2008, Rensis Corporation Claims Attachments Status °Comments on NPRM and lessons from pilot project plus any other proofs of concepts fed back into updates of X12 – version 005010 and HL7 – Clinical Document Architecture Release 2 (CDA R2) implementation guides … for use in Final Rule 31 continued on next slide...

32. Rensis Corporation © 2008, Rensis Corporation Claims Attachments Status °X12 version 005010 TR3’s Public comment period closed 8/30/2006 Informational Forums held 9/26/2006 Published by WPC 7/06/2007 and 4/07/2008 °HL7 CDA R2 Specifications First informative ballot closed 1/04/2007 Second informative ballot closed 4/23/2007 Changes incorporated from both ballots 7 documents in final stages of publication °Final Rule in DHHS clearance 32 continued on next slide...

33. Rensis Corporation © 2008, Rensis Corporation Claims Attachments Status °Joint X12 – HL7 project being re-started to determine what data goes in a claim versus what data goes in a claim attachment 33

34. Rensis Corporation © 2008, Rensis Corporation HIPAA 45 CFR X12N Impl. Guides / TR3’s X12 Transaction Part 162 004010 005010 Standard Claim - Prof.K, R X098 +A1 X222 837 Claim - Inst.K, R X096 +A1 X223 837 Claim - Dent.K, R X097 +A1 X224 837 Eligibility L X092 +A1 X279 270 & 271 Auth. Request M X094 +A1 X217 278 & 278 Claim Status N X093 +A1 X212 276 & 277 Enrollment O X095 +A1 X220 834 Remittance P X091 +A1 X221 835 Premium Pmt. Q X061 +A1 X218 820 Proposed HIPAA Txns. 004050 Claim Additional Info Request X150X213 277 Claim Attachment X151X210 275 34 004010Xnnn +A1 are adopted for HIPAA New Versions of Current Txns.

35. Rensis Corporation © 2008, Rensis Corporation New Versions of Current Txns. X12 version 004010 + 004010A1 Implementation Guides (IG’s) °Remain current HIPAA standards °X12 web site for obtaining interpretations www.x12n.org/portal °DSMO web site for requesting changes www.hipaa-dsmo.org/main.asp °CMS web site for filing complaints https://htct.hhs.gov/aset/ 35

36. Rensis Corporation © 2008, Rensis Corporation New Versions of Current Txns. Writing of X12 version 005010 counterpart TR3’s complete °Changes include Additional useful explanations Accumulated and timely new routine requests National Provider Identifier (NPI) adaptations Modifications to support ICD-10-CM and ICD-10-PCS °New change requests now being considered only for subsequent versions (e.g., 005050) 36

37. Rensis Corporation © 2008, Rensis Corporation New Versions of Current Txns. Adoption status of X12 version 005010 counterpart TR3’s °X12N Public comment periods held during 2005 – 2007 °Published by WPC in 2006 – 2008 °Approved by DSMO in 2007 °Recommended by NCVHS in 2007 °NPRM received by OMB for approval on 5/16/2008 37

38. Rensis Corporation © 2008, Rensis Corporation New Versions of Current Txns. Adoption status of X12 version 005010 counterpart TR3’s °X12N Public comment periods held during 2005 – 2007 °Published by WPC in 2006 – 2008 °Approved by DSMO in 2007 °Recommended by NCVHS in 2007 °NPRM received by OMB for approval on 5/16/2008 38 ° NPRM for revisions to HIPAA code sets received by OMB for approval on 7/11/2008

39. Rensis Corporation © 2008, Rensis Corporation New Versions of Current Txns. NCVHS Recommendations on X12 version 005010 counterpart TR3’s from letter at http://www.ncvhs.hhs.gov/070926lt.pdf Expedite start of HIPAA adoption (i.e., NPRM) process Sequential, non-overlapping, implementations of –version 005010 counterpart transactions –ICD-10-CM and ICD-10-PCS code sets –claims attachments transactions with potentially two years planned for covered entities to achieve version 005010 compliance 39 continued on next slide...

40. Rensis Corporation © 2008, Rensis Corporation New Versions of Current Txns. NCVHS Recommendations on X12 version 005010 counterpart TR3’s Allow industry to test and verify version 005010 transactions (i.e., end-to-end use) up to two years prior to adopting ICD-10-CM and ICD-10-PCS Define, in general, transactions testing levels and requirements: two levels were proposed Develop a plan for covered entities to demonstrate compliance with transactions testing levels and requirements; using, as appropriate –Pilot testing –Testing services 40 continued on next slide...

41. Rensis Corporation © 2008, Rensis Corporation New Versions of Current Txns. NCVHS Recommendations on X12 version 005010 counterpart TR3’s Identify and use communication approaches and materials to educate and inform industry constituencies about all HIPAA standards, and in particular, about version 005010 transactions Take steps to collect, analyze, and disseminate data about at least the version 005010 process, business impacts (both cost and benefit), return on investment, and other information 41

42. Rensis Corporation © 2008, Rensis Corporation New Versions of Current Txns. X12 version 005010 topics to look for in NPRM °Benefits versus costs analysis of moving to version 005010 °Version 005010 testing approach(es) °Request for version 005010 compliance dates recommendations °Request for version 004010 + 004010A1 sunset dates recommendations Alert … downloads of version 005010 TR3’s will cost you this time! 42

43. Rensis Corporation © 2008, Rensis Corporation New Versions of Current Txns. Topics to also look for in NPRM °Replacement National Council for Prescription Drug Programs (NCPDP) transactions Telecommunication Claims Standard version D.0 Batch Claims Standard version 1.2 °New NCPDP transaction Medicaid Subrogation Implementation Guide version 3.0 43

44. Rensis Corporation © 2008, Rensis Corporation Some Potential New Transactions X12 version 005050 counterpart TR3’s °One key focus is functionality to better support Consumer Directed Healthcare Real-time claims adjudication Payments from Healthcare Savings Accounts Faster / real-time eligibility determinations Faster / real-time claim status determinations Improved, unsolicited, payer reporting of claims processing progress °Writing is already in progress 44 continued on next slide...

45. Rensis Corporation © 2008, Rensis Corporation Some Potential New Transactions X12 version 005010 and/or 005050 new TR3’s °Acknowledgements [999, 277, 824] °Authorization Inquiry [278] °Authorization Notification [278] °Authorization Attachment [275] Additional Claims Attachments – HL7 CDA R2 45 Numbers shown in [ ] are X12 transaction sets

46. Rensis Corporation © 2008, Rensis Corporation 46 HIPAA Transactions The Next Generations Further Information Rensis Corporation Seminar: “X12N’s HIPAA Transactions – Putting In Your Oar” Feinberg’s Free Focused HIPAA Mailing List Send e-mail request to one of ° DAFeinberg@computer.org ° HIPAA-TCS-subscribe@yahoogroups.com ° ShareHIPAA-subscribe@yahoogroups.com continued on next slide...

47. Rensis Corporation © 2008, Rensis Corporation 47 HIPAA Transactions The Next Generations Further Information Standards Development Organization (SDO) Meetings °Accredited Standards Committee X12 http://www.x12.org/x12org/meetings/x12trimt/index.cfm °Health Level Seven (HL7) http://www.hl7.org – in Events column, click on Calendar °National Council for Prescription Drug Programs (NCPDP) http://www.ncpdp.org – click on Work Groups continued on next slide...

48. Rensis Corporation © 2008, Rensis Corporation 48 HIPAA Transactions The Next Generations Further Information Next X12 Trimester Meeting is 21-25 September 2008 Pittsburgh, Pennsylvania Agenda will include discussions of X12’s comments on NPRM responses to technical comments received on NPRM

49. Rensis Corporation © 2008, Rensis Corporation Comments? Questions? Other Thoughts? 49 HIPAA Transactions The Next Generations Contact Dave Feinberg

50. Rensis Corporation © 2008, Rensis Corporation David A. Feinberg, C.D.P. President, Rensis Corporation 3662 SW Othello Street Seattle, Washington 98126-3246 206-617-1717DAFeinberg@computer.org 50 HIPAA Transactions The Next Generations